Urinary catheter-insertion kits

ABSTRACT

Urinary catheter-insertion kits can include an upper tray fixed to a lower tray and a separator wall positioned over at least a portion of the urinary catheter assembly. The upper tray can include a preformed catheter section configured to accommodate a urinary catheter of a urinary catheter assembly, and a cutout formed through an end portion of the catheter section. A drainage system of the urinary catheter assembly can be disposed in the lower tray, the drainage system including drainage tubing and a drainage receptacle. The drainage tubing can be connected to the urinary catheter through the cutout in the catheter section of the upper tray. Methods of urinary catheterization include use of the urinary catheter-insertion kits.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.18/126,879, filed Mar. 27, 2023, which is a continuation of U.S. patentapplication Ser. No. 17/058,067, filed Nov. 23, 2020, now U.S. Pat. No.11,612,715, which is a U.S. national stage of International ApplicationNo. PCT/US2019/038051, filed Jun. 19, 2019, which claims the benefit ofpriority to U.S. Provisional Application No. 62/687,656, filed Jun. 20,2018, and to U.S. Provisional Application No. 62/724,292, filed Aug. 29,2018, each of which is incorporated by reference in its entirety intothis application.

BACKGROUND

Urinary catheters are used in healthcare facilities such as hospitals todrain urine from patients. However, the second most common form ofhospital-acquired infection (“HAI”) is catheter-associated urinary tractinfection (“CAUTI”). As such, hospitals are interested in ways to cuttheir CAUTI rates by conforming to strict aseptic techniques as part oftheir standard of care. But there are many factors that influence ahospital's ability to meet that standard of care. These factors includeaspects of healthcare-practitioner training and experience, patientfactors (e.g., general health, weight, and anatomy), environmentalfactors, and characteristics of urinary catheter-insertion kitsincluding components of the kits, various layouts of the components inthe kits, and instructions for use of such kits. There is a need inhealthcare for an easy, safe, and reliable standard method for insertinga catheter into a patient. Disclosed herein are catheter-insertion kits,including urinary catheter insertion kits, with integrated instructionsfor use and methods thereof that address the foregoing.

SUMMARY

Disclosed herein is urinary catheter-insertion kit including, in someembodiments, a working tray, a storage tray, a catheter (by way ofnon-limiting example, a fluid drainage catheter, such as a urinarycatheter), and a drainage system including drainage tubing and adrainage receptacle. The working tray is configured to nest with thestorage tray by suspending the working tray from the storage tray.According to some embodiments, the working tray is fixed to the storagetray to at least substantially prevent their separation. At least theworking tray includes a number of preformed sections configured to holda number of components of the urinary catheter-insertion kit. At leastone section of the preformed sections of the working tray includes acatheter section configured to hold the catheter. The storage tray isconfigured to hold the drainage system.

In some embodiments, suspending the working tray from the storage trayincludes inserting folded-over longitudinal edges or tabs of apaperboard storage tray in a gap between longitudinal sides and anoverhang of the working tray. The gap includes a number of protrusionsconfigured to engage the folded-over longitudinal edges or tabs of thepaperboard storage tray and fasten together the working tray and thestorage tray.

In some embodiments, the storage tray includes a cutout in an end of thestorage tray. The cutout in the end of the storage tray is configured tofacilitate access to any of the components of the urinarycatheter-insertion kit stored in the storage tray while working from theworking tray.

In some embodiments, the working tray includes a cutout in a corner areaof the catheter section formed between a bottom portion and an endportion of the catheter section. The cutout in the corner area of thecatheter section is configured to allow the drainage tubing to pass fromthe storage tray to the working tray by way of a bottom of the cutoutwhen the drainage tubing is stored in the storage tray. According toother embodiments, there is no cut-out but instead the working tray edgenearest the cut-out end of the storage tray is short enough to permitthe drainage tubing to extend from the storage tray to the working tray.

In some embodiments, a side of the cutout in the corner area of thecatheter section is configured to allow the drainage tubing to beremoved from the storage tray without disconnecting the drainage tubingfrom the catheter when the drainage tubing and the catheter arepre-connected in the urinary catheter-insertion kit.

In some embodiments, the working tray includes a drainage-tubingconstriction between the cutout in the corner area of the cathetersection and a remainder of the catheter section. The drainage-tubingconstriction is configured to hold a portion of the drainage tubing andmaintain an initial placement of the urinary catheter in the workingtray until the urinary catheter is used.

In some embodiments, the urinary catheter-insertion kit further includesa connector configured to connect the catheter to the drainage tubing.The connector is pre-connected to at least the catheter in the urinarycatheter-insertion kit. The connector includes a urine-sampling port.

In some embodiments, the urinary catheter-insertion kit further includesa lubricant container including lubricant for the catheter. At least onesection of the preformed sections of the working tray includes alubricant-container section configured to hold the lubricant container.

In some embodiments, the urinary catheter-insertion kit further includesan inflatant container including an inflatant for inflating a balloon ofthe catheter. At least one section of the preformed sections of theworking tray includes an inflatant-container section configured to holdthe inflatant container.

In some embodiments, the urinary catheter-insertion kit further includesa genital-preparation kit including a package of an antiseptic and oneor more swab sticks. At least one section of the preformed sections ofthe working tray includes a genital-preparation section configured witha well to hold the antiseptic from the package. The genital-preparationsection also includes one or more angled channels to respectively holdthe one or more swab sticks with their corresponding one or moreabsorbent heads in the well.

In some embodiments, the well is dimensioned to have a volumecommensurate with an entire volume of the antiseptic from the packageplus a volume of the one or more absorbent heads such that the one ormore absorbent heads become saturated with the antiseptic when theantiseptic from the package is dispensed in the well.

In some embodiments, the urinary catheter-insertion kit further includesa urine-sampling container. At least one section of the preformedsections of the working tray includes a urine sampling-container sectionconfigured to hold the urine-sampling container. Alternatively, thestorage tray is configured to hold the urine-sampling container insteadof the working tray.

In some embodiments, the urinary catheter-insertion kit further includesstep-by-step catheterization instructions imprinted directly on at leastthe working tray.

In some embodiments, the urinary catheter-insertion kit further includesan instruction to not separate the working tray from the storage trayalong with the step-by-step catheterization instructions imprinteddirectly on at least the working tray.

In some embodiments, the urinary catheter-insertion kit further includesprotective paperboard configured to protect at least the components ofthe working tray. The working tray includes a lip around a perimeter ofthe working tray configured to hold the paperboard.

In some embodiments, the urinary catheter-insertion kit further includesa peri-care kit. The urinary catheter-insertion kit is configured toinclude the peri-care kit between the paperboard and an outer packagingof the urinary catheter-insertion kit.

Also disclosed herein is urinary catheter-insertion kit including, insome embodiments, a working tray including a Foley catheter, alubricant-filled syringe for lubricating the catheter, a saline-filledsyringe for inflating a balloon of the catheter, a genital-preparationkit including a package of an antiseptic and one or more swab sticks,and a urine-sampling container; a storage tray including a drainagesystem including drainage tubing and a drainage receptacle; andstep-by-step catheterization instructions imprinted directly on at leastthe working tray. At least the working tray includes a number ofpreformed sections holding a number of components of the urinarycatheter-insertion kit. At least one section of the preformed sectionsof the working tray includes a catheter section including the catheter,a lubricant-syringe section including the lubricant-filled syringe, asaline-syringe section including the saline-filled syringe, and agenital-preparation section including the package of the antiseptic andthe one or more swab sticks. At least one section of the preformedsections of the working tray includes a urine sampling-container sectionincluding the urine-sampling container. Alternatively, the storage trayis configured to hold the urine-sampling container instead of theworking tray. The genital-preparation section is configured with a wellto hold the antiseptic from the package. The genital-preparation sectionalso includes one or more angled channels holding the one or more swabsticks with their absorbent heads in the well. The working tray isconfigured to nest with the storage tray by suspending the working trayfrom the storage tray. The working tray includes a cutout in a cornerarea of the catheter section formed between a bottom portion and an endportion of the catheter section. The drainage system is pre-connected tothe catheter through a connector having a urine-sampling port. Thecutout in the corner area of the catheter section is configured to allowthe drainage tubing to pass from the storage tray where the drainagesystem is stored to the working tray by way of a bottom of the cutout inthe corner area of the catheter section.

In some embodiments, the working tray includes a drainage-tubingconstriction between the cutout in the corner area of the cathetersection and a remainder of the catheter section. The drainage-tubingconstriction is configured to hold a portion of the drainage tubing andmaintain an initial placement of the urinary catheter in the workingtray until the urinary catheter is used.

Also disclosed herein is a method of urinary catheterization with aurinary catheter-insertion kit including, in some embodiments, removingan outer packaging from the urinary catheter-insertion kit, cleaning apatient's perianal area with a peri-care kit, preparing the patient'sgenital area using a genital-preparation kit, and catheterizing thepatient with a Foley catheter. Removing the outer packaging from theurinary catheter-insertion kit bares a working tray suspendedly nestedwith a storage tray with step-by-step catheterization instructionsimprinted directly on at least the working tray. The working trayincludes a number of preformed sections holding a number of componentsfor the method of urinary catheterization with the urinarycatheter-insertion kit. Removing the outer packaging from the urinarycatheter-insertion kit also bares a protective paperboard configured toprotect the components of the urinary catheter-insertion kit in theworking tray under the paperboard. Cleaning the patient's perianal areawith the peri-care kit includes removing the peri-care kit from betweenthe outer packaging of the urinary catheter-insertion kit and thepaperboard over the working tray. Preparing the patient's genital areausing the genital-preparation kit includes using a package of anantiseptic and one or more swab sticks of the genital-preparation kit.Preparing the patient's genital area includes removing the package ofthe antiseptic from a genital-preparation section of the working trayand dispensing the antiseptic into a well of the genital-preparationsection, thereby saturating one or more absorbent heads of one or morecorresponding swab sticks respectively held in one or more angledchannels of the genital-preparation section. Catheterizing the patientwith the catheter includes removing the catheter from a catheter sectionof the working tray and a drainage system from the storage tray withoutdisconnecting the catheter from either drainage tubing or a drainagereceptacle of the drainage system.

In some embodiments, the working tray includes a cutout in a corner areaof the catheter section formed between a bottom portion and an endportion of the catheter section. The cutout enables removing both thecatheter from the catheter section of the working tray and the drainagesystem from the storage tray without disconnecting the catheter from thedrainage system.

In some embodiments, the method further includes removing the drainagetubing from a drainage-tubing constriction in the working tray betweenthe cutout in the corner area of the catheter section and a remainder ofthe catheter section.

In some embodiments, dispensing the antiseptic into the well of thegenital-preparation section of the working tray is in accordance withthe step-by-step catheterization instructions imprinted directly on theworking tray.

In some embodiments, preparing the patient's genital area includesretracting the patient's genitals using a non-dominant hand and swabbingthe patient's genitals with the antiseptic using a dominant hand inaccordance with the step-by-step catheterization instructions imprinteddirectly on the working tray.

In some embodiments, the method further includes removing alubricant-filled syringe from a lubricant-syringe section of the workingtray, dispensing the lubricant from the lubricant-filled syringe intothe catheter section of the working tray, and lubricating the catheterwith the lubricant dispensed in the lubricant-syringe section of theworking tray. At least dispensing the lubricant into the cathetersection and lubricating the catheter with the lubricant dispensed in thecatheter section of the working tray are in accordance with thestep-by-step catheterization instructions imprinted directly on theworking tray.

In some embodiments, the method further includes removing asaline-filled syringe from a saline-syringe section of the working trayand attaching the saline-filled syringe to the catheter for inflating aballoon of the catheter. At least attaching the saline-filled syringe tothe catheter is in accordance with the step-by-step catheterizationinstructions imprinted directly on the working tray.

In some embodiments, catheterizing the patient includes inserting thecatheter into the patient's urethra and inflating the balloon withsaline from the saline-filled syringe. At least inflating the balloonwith saline from the saline-filled syringe is in accordance with thestep-by-step catheterization instructions imprinted directly on theworking tray.

These and other features of the concepts provided herein will becomemore apparent to those of skill in the art in view of the accompanyingdrawings and following description, which disclose particularembodiments of such concepts in greater detail.

DRAWINGS

FIG. 1A provides a perspective view of a urinary catheter-insertion kitincluding at least some components in a working tray of the urinarycatheter-insertion kit in accordance with some embodiments.

FIG. 1B provides a top view of the urinary catheter-insertion kit ofFIG. 1A.

FIG. 1C provides a first cross-sectional view of the urinarycatheter-insertion kit of FIG. 1A.

FIG. 1D provides a second cross-sectional view of the urinarycatheter-insertion kit of FIG. 1A.

FIG. 2A provides a perspective view of alternative nested trays of aurinary catheter-insertion kit in accordance with some embodiments.

FIG. 2B provides a top view of the nested trays of FIG. 2A.

FIG. 3A provides a perspective view of alternative nested trays of aurinary catheter-insertion kit in accordance with some embodiments.

FIG. 3B provides a top view of the nested trays of FIG. 3A.

FIG. 4A illustrates a perspective view of a urinary catheter-insertionkit.

FIG. 4B illustrates another view of the urinary catheter-insertion kit.

FIG. 5 illustrates a urinary catheter insertion kit in accordance withsome embodiments.

FIG. 6A provides a perspective view of alternative nested trays of aurinary catheter-insertion kit in accordance with some embodiments.

FIG. 6B provides a top view of an alternative working tray of a urinarycatheter-insertion kit in accordance with some embodiments.

FIG. 6C provides a top view of an unfolded paperboard precursor of analternative storage tray of a urinary catheter-insertion kit inaccordance with some embodiments.

FIG. 7 provides a cross section of a tray fastening mechanism forfastening together the alternative nested trays of FIG. 6A in accordancewith some embodiments.

DESCRIPTION

Before some particular embodiments are disclosed in greater detail, itshould be understood that the particular embodiments disclosed herein donot limit the scope of the concepts provided herein. It should also beunderstood that a particular embodiment disclosed herein can havefeatures that can be readily separated from the particular embodimentand optionally combined with or substituted for features of any of anumber of other embodiments disclosed herein.

Regarding terms used herein, it should also be understood the terms arefor the purpose of describing some particular embodiments, and the termsdo not limit the scope of the concepts provided herein. Ordinal numbers(e.g., first, second, third, etc.) are generally used to distinguish oridentify different features or steps in a group of features or steps,and do not supply a serial or numerical limitation. For example,“first,” “second,” and “third” features or steps need not necessarilyappear in that order, and the particular embodiments including suchfeatures or steps need not necessarily be limited to the three featuresor steps. Labels such as “left,” “right,” “front,” “back,” “top,”“bottom,” “forward,” “reverse,” “clockwise,” “counter clockwise,” “up,”“down,” or other similar terms such as “upper,” “lower,” “aft,” “fore,”“vertical,” “horizontal,” “proximal,” “distal,” and the like are usedfor convenience and are not intended to imply, for example, anyparticular fixed location, orientation, or direction. Instead, suchlabels are used to reflect, for example, relative location, orientation,or directions. Singular forms of “a,” “an,” and “the” include pluralreferences unless the context clearly dictates otherwise.

With respect to “proximal,” a “proximal portion” or a “proximal endportion” of, for example, a catheter disclosed herein includes a portionof the catheter intended to be near a clinician when the catheter isused on a patient. Likewise, a “proximal length” of, for example, thecatheter includes a length of the catheter intended to be near theclinician when the catheter is used on the patient. A “proximal end” of,for example, the catheter includes an end of the catheter intended to benear the clinician when the catheter is used on the patient. Theproximal portion, the proximal end portion, or the proximal length ofthe catheter can include the proximal end of the catheter; however, theproximal portion, the proximal end portion, or the proximal length ofthe catheter need not include the proximal end of the catheter. That is,unless context suggests otherwise, the proximal portion, the proximalend portion, or the proximal length of the catheter is not a terminalportion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal end portion”of, for example, a catheter disclosed herein includes a portion of thecatheter intended to be near or in a patient when the catheter is usedon the patient. Likewise, a “distal length” of, for example, thecatheter includes a length of the catheter intended to be near or in thepatient when the catheter is used on the patient. A “distal end” of, forexample, the catheter includes an end of the catheter intended to benear or in the patient when the catheter is used on the patient. Thedistal portion, the distal end portion, or the distal length of thecatheter can include the distal end of the catheter; however, the distalportion, the distal end portion, or the distal length of the catheterneed not include the distal end of the catheter. That is, unless contextsuggests otherwise, the distal portion, the distal end portion, or thedistal length of the catheter is not a terminal portion or terminallength of the catheter.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by those of ordinary skillin the art.

Urinary catheters are used in healthcare facilities such as hospitals todrain urine from patients. However, the second most common form ofhospital-acquired infection (“HAI”) is catheter-associated urinary tractinfection (“CAUTI”). As such, hospitals are interested in ways to cuttheir CAUTI rates by conforming to strict aseptic techniques as part oftheir standard of care. But there are many factors that influence ahospital's ability to meet that standard of care. These factors includeaspects of healthcare-practitioner training and experience, patientfactors (e.g., general health, weight, and anatomy), environmentalfactors, and characteristics of urinary catheter-insertion kitsincluding components of the kits, various layouts of the components inthe kits, and instructions for use of such kits. There is a need inhealthcare for an easy, safe, and reliable standard method for insertinga urinary catheter into a patient. Disclosed herein are urinarycatheter-insertion kits with integrated instructions for use and methodsthereof that provide an easy, safe, and reliable standard method forinserting a urinary catheter into a patient, thereby reducing CAUTIrates.

Urinary Catheter-Insertion Kits

FIG. 1A provides a perspective view of a urinary catheter-insertion kit100 including at least some components in a working tray 110 of theurinary catheter-insertion kit 100 in accordance with some embodiments.FIGS. 1B-1D provide different views of the urinary catheter-insertionkit 100 of FIG. 1A. Additional components not shown in FIGS. 1A-1D thatare useful in the urinary catheter-insertion kit 100 can be found inU.S. Pat. Nos. 10,758,705 and 10,905,848, each of which is incorporatedby reference in its entirety into this application. Such components caninclude, but are not limited to, any one or more components selectedfrom a stabilization device (e.g., C. R. Bard, Inc.'s StatLock® Foleystabilization device), prepping balls (e.g., absorbent cotton balls),forceps, a label that can be filled out with catheterization orurine-sampling details, a fenestrated drape to place over a patient, anunderpad to place under the patient, gloves (e.g., a package of latex orlatex-free gloves), a sterile wrap (e.g., Central Supply Room [“CSR”]wrap) to wrap around the working and storage trays, a belly band (e.g.,to hold the sterile wrap in place around the working and storage trays),hand sanitizer, moist towelettes (e.g., a package of castile-soaptowelettes), additional instructions to those imprinted on at least theworking tray (e.g., an instruction sheet for a clinician, an instructionpamphlet for the patient, etc.), a checklist of safety considerations, apatient information chart, an insert sheet, and a packaging label. FIGS.2A and 2B provide different views of alternative nested trays of theurinary catheter-insertion kit 100 in accordance with some embodiments.FIGS. 3A and 3B provide different views of further alternative nestedtrays of the urinary catheter-insertion kit 100 in accordance with someembodiments. FIG. 6A provides a perspective view of yet furtheralternative trays of the urinary catheter-insertion kit 100 inaccordance with some embodiments.

The urinary catheter-insertion kit 100 can include a working tray 110, astorage tray 120, a urinary catheter 132 (e.g., a Foley catheter), and adrainage system (not shown) including drainage tubing and a drainagereceptacle (e.g., drainage bag, optionally including a urine meter).(See U.S. Pat. Nos. 10,758,705 and 10,905,848 for description of thedrainage system, which can include a urine meter in addition to thedrainage tubing and the drainage receptacle.)

The working tray 110 can be configured to nest with the storage tray 120by suspending the working tray 110 from the storage tray 120. At leastthe working tray 110 can include a number of preformed sectionsconfigured to respectively hold a number of components of the urinarycatheter-insertion kit 100. For example, at least one section of thepreformed sections of the working tray 110 can include a cathetersection 112 configured to hold the catheter 132.

The storage tray 120 can include an opening such as a cutout 121 in anend of the storage tray 120. The opening such as the cutout 121 in theend of the storage tray 120 can be configured to facilitate access toany of the components of the urinary catheter-insertion kit 100 storedin the storage tray 120 while working from the working tray 110. Forexample, until needed, the drainage system can be stored in the storagetray 120 while working from the working tray 110. The opening or thecutout 121 also allows access to a bottom of the working tray 110, ifneeded, to lift the working tray 110 out of the storage tray 120 whilesupporting the bottom of the working tray 110. That said, the workingtray 110 can be fixed (e.g., fastened, bonded, etc.) to the storage tray120 in some embodiments. In such embodiments, the urinarycatheter-insertion kit 100 is designed such that the working tray 110remains fixed to the storage tray 120 throughout a catheterizationprocedure. Indeed, as shown in FIG. 6B, an instruction can be includedalong with step-by-step catheterization instructions imprinted directlyon at least the working tray 110 to not separate the working tray 110from the storage tray 120.

The storage tray 120 of FIG. 6A is a folded paperboard storage tray ofthe urinary catheter-insertion kit 100. FIG. 6C provides an unfoldedpaperboard precursor to the foregoing folded paperboard storage tray.Once the paperboard precursor is folded along the fold lines shown, theresulting storage tray 120 includes folded-over longitudinal edgesconfigured to engage a number of protrusions (see FIG. 6A) molded intothe working tray 110, thereby forming a portion of a fastening mechanism(see FIG. 7 ) for fastening together the working tray 110 and thestorage tray 120. As an alternative to the folded-over longitudinaledges, the paperboard precursor of FIG. 6C can include a number of tabsalong the longitudinal edges thereof configured to form upon folding thepaperboard precursor a number of folded-over tabs configured to engagethe number of protrusion molded into the working tray 110.

The working tray 110 can include a cutout 111 in a corner area of thecatheter section 112 formed between a bottom portion and an end portionof the catheter section 112. The cutout 111 in the corner area of thecatheter section 112 can be configured to allow, for example, thedrainage tubing of the drainage system to pass from the storage tray 120to the working tray 110 by way of a bottom of the cutout 111 when thedrainage tubing is stored in the storage tray 120. A side of the cutout111 in the corner area of the catheter section 112 can be configured toallow the drainage tubing to be removed from the storage tray 120without disconnecting the drainage tubing from the catheter 132 when thedrainage system and the catheter 132 are pre-connected in the urinarycatheter-insertion kit 100 as set forth below. In contrast, if the endportion of the catheter section 112 is intact and the cutout 111consists of only the bottom portion of the catheter section 112 (i.e.,the cutout 111 is a hole in the bottom portion of the catheter section112), the drainage tubing and, subsequently, the catheter 132 would haveto be pulled through the cutout 111 when the drainage system and thecatheter 132 are pre-connected, which risks contamination of thecatheter 132. Alternatively, the drainage tubing would have to bedisconnected from the catheter 132 when the drainage system and thecatheter 132 are pre-connected, which also risks contamination of thecatheter 132 by way of either disconnecting the drainage tubing from thecatheter 132 or reconnecting the drainage tubing to the catheter 132.

The working tray 110 can include a drainage-tubing constriction 113between the cutout 111 in the corner area of the catheter section 112and a remainder of the catheter section 112 as shown in FIG. 6B. Thedrainage-tubing constriction 113 can be configured to hold a portion ofthe drainage tubing when the drainage system and the catheter 132 arepre-connected. By holding the drainage tubing in the drainage-tubingconstriction 113, an initial or as-manufactured placement of theforegoing pre-connected urinary catheter 132 in the working tray 110 canbe maintained until the urinary catheter 120 is used for urinarycatheterization. As shown, the drainage-tubing constriction 113 caninclude snap-in tabs configured to hold the drainage tubing in thedrainage-tubing constriction 113.

The working tray 110 can include a number of lugs 104 projecting from abottom side of the working tray 110. Each lug of the number of lugs 104also forms a well in a top side of the working tray 110 as shown in FIG.6A. Notably, while the number of lugs 104 are shown in sets of threeabout the working tray 110 such as the four sets of three lugs 104respectively at or near the four corners of the working tray 110, onlyone lug of each set of lugs 104 is present in any particular workingtray 110. For example, a first lug of each set of lugs 104 can bepresent in a first working tray 110, a second lug of each set of lugs104 can be present in a second working tray 110, and a third lug of eachset of lugs 104 can be present in a third working tray 110, not one ofwhich working trays matches another on account of the number of lugs104. Indeed, the number of lugs 104 are configured to prevent two ormore working trays including the number of lugs 104 to nest too tightlytogether such as after molding (e.g., thermoforming) two or more of theforegoing working trays and nesting them together.

The working tray 110 can include a number of indentations 108 in atleast longitudinal sides of the working tray 110, as viewed from withina working area of the working tray 110. (See, for example, FIGS. 6A and7 .) The number of indentations 108 correspondingly provide a number ofprojections between at least the longitudinal sides of the working tray110 and an overhang 122 (see FIG. 7 ) of the working tray 120, therebyforming another portion of the fastening mechanism for fasteningtogether the working tray 110 and the storage tray 120. With theoverhang 122, the working tray 110 is configured for insertion of thefolded-over longitudinal edges or tabs of the storage tray 120 of FIG.6A in a gap between the longitudinal sides of the working tray 110 andthe overhang 122. As shown, the number of projections provided by way ofthe number of indentations 108 are configured to engage the folded-overlongitudinal edges or tabs of the storage tray 120, thereby fasteningtogether the working tray 110 and the storage tray 120 and preventingseparation thereof. Notably, the gap between the longitudinal sides andthe overhang 122 of the working tray 110 are dimensioned to provide thefolded-over longitudinal edges or tabs of the storage tray 120 room toexpand under a spring force within folds of the folded-over longitudinaledges or tabs created by forcing the longitudinal edges or tabs intolongitudinal sides of the paperboard of the storage tray 120. Inaddition, the number of protrusions protrude as sharply as molding(e.g., thermoforming) allows making engaging surfaces of the number ofprotrusions as flat as possible for engaging the folded-overlongitudinal edges or tabs of the storage tray 120. The foregoingfastening mechanism shown in FIG. 7 obviates a need for a secondarymechanism (e.g., bonding) for fastening the working tray 110 and thestorage tray 120 together.

The catheter 132 can be pre-connected to the drainage system to minimizeany potential failures in connecting the catheter 132 to the drainagesystem, which, in turn, can minimize any potential contamination.Between the catheter 132 and the drainage tubing, a connector 134 can beused to connect the catheter 132 and the drainage tubing. The connector134 can include a urine-sampling port configured to facilitate urinesampling.

At least one section of the preformed sections of the working tray 110can include a lubricant well 109 configured to hold lubricant dispensedinto the lubricant well 109 for lubricating the catheter 132. Forexample, the embodiments of FIGS. 1A-1D, 3A, and 3B include thelubricant well 109 as part of the catheter section 112. Alternatively,the working tray 110 does not include the lubricant well 109 butincludes another section additionally configured for lubricating thecatheter 132. For example, the embodiment of FIGS. 2A and 2B do notinclude the lubricant well 109 as part of the catheter section 112 butinclude additional space in place of the lubricant well 109 to holddispensed lubricant for lubricating the catheter 132.

The urinary catheter-insertion kit 100 can further include a lubricantcontainer 136 (e.g., syringe, packet, pod, vial, etc.) including,containing, or filled with lubricant for the catheter 132. At least onesection of the preformed sections of the working tray 110 can include alubricant-container section 114 (e.g., lubricant-syringe section,lubricant-packet section, lubricant-pod section, lubricant-vial section,etc.) configured to hold the lubricant container 136. Thelubricant-container section 114 can be preformed to accommodate thelubricant container 136; however, the lubricant-container section 114need not conform to every feature of the lubricant container 136. Forexample, if the lubricant container 136 is a syringe, thelubricant-container section 114 (e.g., lubricant-syringe section) neednot include a recess for a flange of the syringe. That is, thelubricant-container section 114 can have a constant width or depthcommensurate with at least the flange of the syringe to accommodate thesyringe. Indeed, the lubricant-container section 114 can have a constantwidth or depth commensurate with the greatest width or diameter of anytype lubricant container 136 set forth herein.

The urinary catheter-insertion kit 100 can further include an inflatantcontainer 138 (e.g., syringe) including, containing, or filled with aninflatant (e.g., saline) for inflating a balloon of the catheter 132. Atleast one section of the preformed sections of the working tray 110 caninclude an inflatant-container section 116 (saline-syringe section)configured to hold the inflatant container 138. The inflatant-containersection 116 can be preformed to accommodate the inflatant container 138;however, the inflatant-container section 116 need not conform to everyfeature of the inflatant container 138. For example, if the inflatantcontainer 138 is a syringe, the inflatant-container section 116 (e.g.,saline-syringe section) need not include a recess for a flange of thesyringe. That is, the inflatant-container section 116 can have aconstant width or depth commensurate with at least the flange of thesyringe to accommodate the syringe. Indeed, the inflatant-containersection 116 can have a constant width or depth commensurate with thegreatest width or diameter of any type inflatant container 138 set forthherein.

As shown, the lubricant-container section 114 and theinflatant-container section 116 can be commensurate in shape and size.For example, the lubricant-container section 114 and theinflatant-container section 116 can have a same length, width, depthfrom common top surface of the working tray 110, or a combinationthereof. Alternatively, each of the lubricant-container section 114 andthe inflatant-container section 116 can have a different shape or sizeas shown in FIG. 6B. An opening between the lubricant-container section114 and the inflatant-container section 116 as shown in each figure ofFIGS. 1B, 2B, 3B, 4B, and 6B provides an access space configured for alateral approach to scooping up the lubricant container 136 or theinflatant container 138 with one or more fingers and removing it fromthe working tray 110. If either container of the lubricant container 136or the inflatant container 138 is a syringe, the lateral approachobviates handling the syringe by way of a longitudinal approach, whichprevents accidental dispensation of the lubricant or the inflatant bypushing a plunger of the syringe into a barrel thereof. Since eachsection of the lubricant-container section 114 and theinflatant-container section 116 is commensurate with the greatest widthor diameter of the lubricant container 136 or the inflatant container138, the opening can be anywhere along a length of the foregoingsections. That is, the opening is not needed to accommodate any portionof either one of the lubricant container 136 or the inflatant container138. However, to further prevent accidental dispensation of thelubricant or the inflatant when either the lubricant container 136 orthe inflatant container 138 is a syringe, it is beneficial to have theopening around the barrel of the syringe to promote handling the syringeby the barrel.

The urinary catheter-insertion kit 100 can further include agenital-preparation kit including a package of an antiseptic (not shown)and one or more swab sticks 144. (See U.S. Pat. Nos. 10,758,705 and10,905,848 for description of the genital-preparation kit.) At least onesection of the preformed sections of the working tray 110 can include agenital-preparation section 118 configured with a well 117 to hold theantiseptic (e.g., povidone-iodine solution) from the package. Thegenital-preparation section 118 can also include one or more angledchannels 119 to respectively hold the one or more swab sticks 144 withtheir corresponding one or more absorbent heads in the well 117. Thewell 117 is dimensioned to have a volume commensurate with an entirevolume of the antiseptic from the package plus a volume of the one ormore absorbent heads such that the one or more absorbent heads becomesaturated with the antiseptic when the antiseptic from the package isdispensed in the well 117. As shown, the one or more angled channels 119can include snap-in tabs 121 configured to hold the one or more swabsticks respectively in the one or more angled channels 119.

The urinary catheter-insertion kit 100 can further include aurine-sampling container 152. At least one section of the preformedsections of the working tray 110 can include a urine sampling-containersection 115 configured to hold the urine-sampling container 152. (Seethe embodiments of FIGS. 1A-1D, 2A, and 2B.) Alternatively, the storagetray 120 can be configured to hold the urine-sampling container 152instead of the working tray 110. (See, for example, the embodiment ofFIGS. 3A and 3B, which does not include the urine sampling-containersection 115 in the working tray 110.) Configuring the storage tray 120to hold the urine-sampling container 152 instead of the working tray 110minimizes a height of the working tray 110.

The urinary catheter-insertion kit 100 can further include step-by-stepcatheterization instructions 102 imprinted directly on at least theworking tray 110. At least some of the instructions 102 can be placed ina location that expressly or implicitly suggests by way of the locationhow to perform a step of the catheterization. For example, thegenital-preparation section 118 can include an express instruction inthe genital-preparation section 118 such as in the well 117 fordispensing the antiseptic from the package thereof into the well 117.(See, for example, FIG. 2B.) For example, the catheter section 112 caninclude an implicit instruction in the catheter section 112 fordispensing the lubricant into the catheter section 112 for lubricatingthe catheter 132. (See, for example, the instruction on the support inthe middle of the catheter section 112 of the working tray 110 of FIG.6B.) At least some of the instructions 102 can be revealed in step withsteps of the catheterization. For example, removing the package ofantiseptic from the genital-preparation section 118 can reveal theinstruction to dispense the antiseptic from the package into the well117 of the genital-preparation section 118 for saturating the one ormore absorbent heads of the corresponding one or more swab sticks withthe antiseptic. Revealing steps of the catheterization instructions 102in this way does not overwhelm the clinician preforming thecatheterization with too many steps at once.

The urinary catheter-insertion kit 100 can further include protectivepaperboard (not shown) configured to protect at least the components ofthe working tray 110. The working tray 110 can include a lip 101 arounda perimeter of the working tray 110 configured to hold the paperboard.

The urinary catheter-insertion kit 100 can further include a peri-carekit (not shown). (See U.S. Pat. Nos. 10,758,705 and 10,905,848, each ofwhich is incorporated by reference in its entirety herein, fordescription of the peri-care kit.) The urinary catheter-insertion kit100 can be configured to include the peri-care kit between thepaperboard and an outer packaging (e.g., Tyvek®) of the urinarycatheter-insertion kit 100.

As such the urinary catheter-insertion kit 100 includes, in someembodiments, the working tray 110 including the urinary catheter 132,the lubricant container 136 including a lubricant for lubricating thecatheter 132, the inflatant container 138 including an inflatant forinflating a balloon of the catheter 132, and a genital-preparation kitincluding a package of an antiseptic and the one or more swab sticks144; the storage tray 120 including a drainage system including drainagetubing and a drainage receptacle; the step-by-step catheterizationinstructions 102 imprinted directly on at least the working tray 110;and an outer packaging of Tyvek® around the urinary catheter-insertionkit 100. At least the working tray 110 includes a number of preformedsections respectively holding a number of components of the urinarycatheter-insertion kit 100. The preformed sections of the working tray110 include at least the catheter section 112 including the catheter132, the lubricant-container section 114 including the lubricantcontainer 136, the inflatant-container section 116 including theinflatant container 138, and the genital-preparation section 118including the package of the antiseptic and the one or more swab sticks144. The preformed sections of the working tray 110 include thestep-by-step catheterization instructions 102 imprinted directly on atleast the working tray 110 without express identification on the workingtray 110 of the number of components.

The catheter section 112 is configured to hold the lubricant dispensedfrom the lubricant container 136 when lubricating the catheter 132. Thelubricant-container section 114 and the inflatant-container section 116have the same constant depth from the common top surface of the workingtray 110. The genital-preparation section 118 is configured with thewell 117 to hold the antiseptic from the package. Thegenital-preparation section 118 also includes the one or more angledchannels 119 holding the one or more swab sticks 144 with theirabsorbent heads in the well 118. The working tray 110 is fixed to thestorage tray 120 in a nested configuration in which the working tray 110is suspended from the storage tray 120. The working tray 110 includesthe cutout 111 in the corner area of the catheter section 112 formedbetween a bottom portion and an end portion of the catheter section 112.The drainage system is pre-connected to the catheter 132 through theconnector 134 having the urine-sampling port. The cutout 111 in thecorner area of the catheter section 112 is configured to allow thedrainage tubing to pass from the storage tray 120 where the drainagesystem is stored to the working tray 110 by way of a bottom of thecutout 111 in the corner area of the catheter section 112.

As such the urinary catheter-insertion kit 100 also includes, in someembodiments, the working tray 110 including a Foley catheter, alubricant-filled syringe for lubricating the catheter 132, asaline-filled syringe for inflating a balloon of the catheter 132, agenital-preparation kit including a package of an antiseptic and the oneor more swab sticks 144, and the urine-sampling container 152; thestorage tray 120 including a drainage system including drainage tubingand a drainage receptacle; and the step-by-step catheterizationinstructions 102 imprinted directly on at least the working tray 110. Atleast the working tray 110 includes a number of preformed sectionsrespectively holding a number of components of the urinarycatheter-insertion kit 100. The preformed sections of the working tray110 include at least the catheter section 112 including the catheter132, a lubricant-syringe section including the lubricant-filled syringe,a saline-syringe section including the saline-filled syringe, and thegenital-preparation section 118 including the package of the antisepticand the one or more swab sticks 144. At least one section of thepreformed sections of the working tray 110 includes the urinesampling-container section 115 including the urine-sampling container152.

Alternatively, the storage tray 120 is configured to hold theurine-sampling container 152 instead of the working tray 110. Thegenital-preparation section 118 is configured with the well 117 to holdthe antiseptic from the package. The genital-preparation section 118also includes the one or more angled channels 119 holding the one ormore swab sticks 144 with their absorbent heads in the well 118. Theworking tray 110 is configured to nest with the storage tray 120 bysuspending the working tray 110 from the storage tray 120. The workingtray 110 includes the cutout 111 in the corner area of the cathetersection 112 formed between a bottom portion and an end portion of thecatheter section 112. The drainage system is pre-connected to thecatheter 132 through the connector 134 having the urine-sampling port.The cutout 111 in the corner area of the catheter section 112 isconfigured to allow the drainage tubing to pass from the storage tray120 where the drainage system is stored to the working tray 110 by wayof a bottom of the cutout 111 in the corner area of the catheter section112.

FIG. 4A illustrates another embodiment of the present invention. Urinarycatheter-insertion kit 200 includes a urine sampling container section215, syringe compartment 214, a second syringe compartment 216, and abase 250 that separates the working tray from the storage tray.According to certain embodiments, the base 250 is configured to besecured to the working tray, e.g., the base 250 is not configured to beremoved. Features 260 a-260 e are configured to assist in securelyfastening the base 250 between the working and storage trays.

FIG. 4B illustrates another embodiment of the tray of FIG. 4A, includingworking tray 210 and storage tray 220, which can include an opening 221in an end of the storage tray 220.

FIG. 5 illustrates yet another embodiment of a catheter-insertion trayin accordance with the present disclosure. Base 250 has an elevatedportion 252 allowing for more room in the storage tray. Moreover,feature 260 c is absent according to this embodiment.

Methods

Methods of urinary catheterization with a urinary catheter-insertion kit100 can include, in some embodiments, removing an outer packaging fromthe urinary catheter-insertion kit 100, cleaning a patient's perianalarea with a peri-care kit, preparing the patient's genital area using agenital-preparation kit, and catheterizing the patient with the catheter132 (e.g., a Foley catheter). Removing the outer packaging from theurinary catheter-insertion kit 100 can bare the working tray 110suspendedly nested with the storage tray 120 with the step-by-stepcatheterization instructions 102 imprinted directly on at least theworking tray 110. The working tray 110 can include a number of preformedsections respectively holding a number of components for the method ofurinary catheterization with the urinary catheter-insertion kit 100.Removing the outer packaging from the urinary catheter-insertion kit 100can also bare a protective paperboard configured to protect thecomponents of the urinary catheter-insertion kit 100 in the working tray110 under the paperboard.

Cleaning the patient's perianal area with the peri-care kit can includeremoving the peri-care kit from between the outer packaging of theurinary catheter-insertion kit 100 and the paperboard over the workingtray 110. Preparing the patient's genital area using thegenital-preparation kit can include using a package of an antiseptic andthe one or more swab sticks 144 of the genital-preparation kit.Preparing the patient's genital area can include removing the package ofthe antiseptic from the genital-preparation section 118 of the workingtray 110, opening the package of the antiseptic, and dispensing theantiseptic into the well 117 of the genital-preparation section 118,thereby saturating one or more absorbent heads of the one or morecorresponding swab sticks 144 respectively held in the one or moreangled channels 119 of the genital-preparation section 118.Catheterizing the patient with the catheter 132 can include removing thecatheter 132 from the catheter section 112 of the working tray 110 and adrainage system from the storage tray 120 without disconnecting thecatheter 132 from either drainage tubing or a drainage receptacle of thedrainage system.

The working tray 110 can include the cutout 111 in the corner area ofthe catheter section 112 formed between a bottom portion and an endportion of the catheter section 112. The cutout 111 can enable removingboth the catheter 132 from the catheter section 112 of the working tray110 and the drainage system from the storage tray 120 withoutdisconnecting the catheter 132 from the drainage system. If the workingtray 110 includes the drainage-tubing constriction 113, removing boththe catheter 132 from the working tray 110 and the drainage system fromthe storage tray 120 includes removing the drainage tubing from thedrainage-tubing constriction 113 in the working 110.

Opening the package of the antiseptic and dispensing the antiseptic intothe well 117 of the genital-preparation section 118 of the working tray110 can be in accordance with the step-by-step catheterizationinstructions 102 imprinted directly on the working tray 110. Thesecatheterization instructions 102 are shown in FIGS. 2B and 3B as thefirst and second steps of the method imprinted directly on the workingtray 110.

Preparing the patient's genital area can include retracting thepatient's genitals using a non-dominant hand and swabbing the patient'sgenitals with the antiseptic using a dominant hand in accordance withthe step-by-step catheterization instructions 102 imprinted directly onthe working tray 110. These catheterization instructions 102 are shownin FIGS. 2B and 3B as the fifth and sixth steps of the method imprinteddirectly on the working tray 110.

The method can further include removing a lubricant-filled syringe froma lubricant-syringe section of the working tray 110, dispensing thelubricant from the lubricant-filled syringe into the lubricant-syringesection, the catheter section 112, or another preformed section of theworking tray 110, and lubricating the catheter 132 with the lubricantdispensed in the working tray 110. At least dispensing the lubricantinto a preformed section of the working tray 110 (e.g., the cathetersection 112) and lubricating the catheter 132 with the lubricantdispensed in the working tray 110 can be in accordance with thestep-by-step catheterization instructions 102 imprinted directly on theworking tray 110. This catheterization instruction is shown in FIGS. 2Band 3B as the fourth step of the method imprinted directly on theworking tray 110. Removing the lubricant-filled syringe from thelubricant-syringe section can reveal the catheterization instructionimprinted in a bottom of the lubricant-syringe section to dispense thelubricant from the lubricant-filled syringe into the catheter section112 for lubricating the catheter 132. Revealing steps of thecatheterization instructions 102 in this way keeps the clinicianperforming the catheterization from becoming overwhelmed by too manysteps at once.

The method further can include removing a saline-filled syringe from asaline-syringe section of the working tray 110 and attaching thesaline-filled syringe to the catheter 132 for inflating a balloon of thecatheter 132. At least attaching the saline-filled syringe to thecatheter 132 can be in accordance with the step-by-step catheterizationinstructions 102 imprinted directly on the working tray 110. Thiscatheterization instruction is shown in FIGS. 2B and 3B as the thirdstep of the method imprinted directly on the working tray 110.

Catheterizing the patient can include inserting the catheter 132 intothe patient's urethra and inflating the balloon with saline from thesaline-filled syringe. At least inflating the balloon with saline fromthe saline-filled syringe can be in accordance with the step-by-stepcatheterization instructions 102 imprinted directly on the working tray110. This catheterization instruction is shown in FIGS. 2B and 3B as theseventh step of the method imprinted directly on the working tray 110.

While some particular embodiments have been disclosed herein, and whilethe particular embodiments have been disclosed in some detail, it is notthe intention for the particular embodiments to limit the scope of theconcepts provided herein. Additional adaptations and/or modificationscan appear to those of ordinary skill in the art, and, in broaderaspects, these adaptations and/or modifications are encompassed as well.Accordingly, departures may be made from the particular embodimentsdisclosed herein without departing from the scope of the conceptsprovided herein.

What is claimed is:
 1. A urinary catheter-insertion kit, comprising: anupper tray fixed to a lower tray, the upper tray comprising: a preformedcatheter section configured to accommodate a urinary catheter of aurinary catheter assembly; and a cutout formed through an end portion ofthe catheter section; a drainage system of the urinary catheter assemblydisposed in the lower tray, the drainage system including drainagetubing and a drainage receptacle, the drainage tubing connected to theurinary catheter through the cutout in the catheter section of the uppertray; and a separator wall positioned over at least a portion of theurinary catheter assembly.
 2. The urinary catheter-insertion kitaccording to claim 1, wherein the separator wall is between the at leasta portion of the urinary catheter assembly and one or more components ofthe urinary catheter-insertion kit.
 3. The urinary catheter-insertionkit according to claim 2, wherein the upper tray is nested on top of thelower tray by inserting folded-over longitudinal edges or tabs of thelower tray in a gap between longitudinal sides and an overhang of theupper tray, the gap including protrusions configured to engage thefolded-over longitudinal edges or tabs of the lower tray and fastentogether the upper tray and the lower tray.
 4. The urinarycatheter-insertion kit according to claim 1, wherein the lower trayincludes a second cutout in an end of the lower tray designed tofacilitate access to the drainage system in the lower tray while workingfrom the upper tray.
 5. The urinary catheter-insertion kit according toclaim 1, wherein the cutout of the catheter section is configured forthe drainage tubing to be removed from the lower tray withoutdisconnecting the drainage tubing from the urinary catheter.
 6. Theurinary catheter-insertion kit according to claim 1, wherein the uppertray includes a drainage-tubing constriction configured to hold aportion of the drainage tubing and maintain an initial placement of theurinary catheter in the upper tray until the urinary catheter is readyfor use.
 7. The urinary catheter-insertion kit according to claim 1,wherein the urinary catheter-insertion kit further comprises a connectorincluding a urine-sampling port configured to connect the urinarycatheter to the drainage tubing, wherein the connector is pre-connectedto the urinary catheter in the urinary catheter-insertion kit.
 8. Theurinary catheter-insertion kit according to claim 1, wherein the urinarycatheter-insertion kit further comprises a lubricant container includinglubricant for the urinary catheter, wherein the upper tray includes apreformed lubricant-container section configured to hold the lubricantcontainer.
 9. The urinary catheter-insertion kit according to claim 8,wherein the urinary catheter-insertion kit further comprises aninflatant container including an inflatant for inflating a balloon ofthe urinary catheter, wherein the upper tray includes a preformedinflatant-container section configured to hold the inflatant container.10. The urinary catheter-insertion kit according to claim 9, wherein theurinary catheter-insertion kit further comprises a genital-preparationkit including a package of an antiseptic and one or more swab sticks,wherein the upper tray includes a preformed genital-preparation sectionconfigured with a well to hold the antiseptic from the package and oneor more angled channels to respectively hold the one or more swab stickswith their corresponding one or more absorbent heads in the well. 11.The urinary catheter-insertion kit according to claim 10, wherein thewell is dimensioned to have a volume commensurate with an entire volumeof the antiseptic from the package plus a volume of the one or moreabsorbent heads such that the one or more absorbent heads becomesaturated with the antiseptic when the antiseptic from the package isdispensed in the well.
 12. The urinary catheter-insertion kit accordingto claim 9, wherein the urinary catheter-insertion kit further comprisesa urine-sampling container, wherein the upper tray includes a preformedurine sampling-container section configured to hold the urine-samplingcontainer.
 13. The urinary catheter-insertion kit according to claim 9,wherein the urinary catheter-insertion kit further comprises aurine-sampling container, wherein the lower tray is designed to hold theurine-sampling container.
 14. The urinary catheter-insertion kitaccording to claim 1, further comprising step-by-step catheterizationinstructions imprinted on the upper tray.
 15. The urinarycatheter-insertion kit according to claim 14, further comprising aninstruction to not separate the upper tray from the lower tray imprintedon the upper tray.
 16. The urinary catheter-insertion kit according toclaim 1, wherein the lower tray comprises paperboard.
 17. The urinarycatheter-insertion kit according to claim 16, wherein the paperboardincludes longitudinal edges configured to fixedly engage with the uppertray.
 18. The urinary catheter-insertion kit according to claim 1,wherein the separator wall comprises a protective paperboard configuredto protect components of the urinary catheter-insertion kit.
 19. Theurinary catheter-insertion kit according to claim 18, further comprisingan outer packaging encompassing the upper tray, the lower tray, andcomponents of the urinary catheter-insertion kit.
 20. The urinarycatheter-insertion kit according to claim 19, wherein the urinarycatheter-insertion kit further comprises a peri-care kit between theprotective paperboard and the outer packaging of the urinarycatheter-insertion kit.